Development of advanced therapies in Italy: Management models and sustainability in six Italian cell factories

Giuseppe Gaipa, Martino Introna, Josee Golay, Maria Luisa Nolli, Giuliana Vallanti, Eugenio Parati, Rosaria Giordano, Luca Romagnoli, Mario Melazzini, Andrea Biondi, Ettore Biagi

Research output: Contribution to journalArticlepeer-review

Abstract

On November 10, 2014, the representatives of all six certified Good Manufacturing Practices (GMP) cell factories operating in the Lombardy Region of Italy convened a 1-day workshop in Milan titled "Management Models for the Development And Sustainability of Cell Factories: Public-Private Partnership?" The speakers and panelists addressed not only the many scientific, technological and cultural challenges faced by Lombardy Cell Factories, but also the potential impact of advanced therapy medicinal products (ATMPs) on public health and the role played by translational research in this process. Future perspectives for research and development (R&D) and manufacturing processes in the field of regenerative medicine were discussed as well. This report summarizes the most important issues raised by the workshop participants with particular emphasis on strengths and limitations of the R&D and manufacturing processes for innovative therapeutics in Lombardy and what can be improved in this context while maintaining GMP standards. The participants highlighted several strategies to translate patient-specific advanced therapeutics into scaled manufacturing products for clinical application. These included (i) the development of a synergistic interaction between public and private institutions, (ii) better integration with Italian regulatory agencies and (iii) the creation of a network among Lombardy cell factories and other Italian and European institutions.

Original languageEnglish
Pages (from-to)481-486
Number of pages6
JournalCytotherapy
Volume18
Issue number4
DOIs
Publication statusPublished - Apr 1 2016

Keywords

  • Advanced therapies medicinal products
  • Cell factories
  • Clinical research
  • Good manufacturing practice

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy
  • Oncology
  • Genetics(clinical)
  • Transplantation
  • Cancer Research
  • Cell Biology

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